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Quantitative Pharmacologist

Company: AVROBIO
Location: Cambridge
Posted on: January 15, 2021

Job Description:

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life. Job Summary We are looking for a Pharmacometrician/Quantitative Pharmacologist who is passionate about their profession and inspired by being part of a team, working in life sciences, to bring Lentiviral Gene Therapy to patients. As a Pharmacometrician/Quantitative Pharmacologist for Lentiviral Gene Therapy, you will support the development of these novel therapeutic modalities from early phase to late phase and regulatory submissions. This individual demonstrates significant knowledge of pharmacometrics/quantitative pharmacology and will be responsible to apply novel translational PK/PD and PBPK modelling expertise to understand efficacy, safety and durability of Lentiviral Gene Therapy throughout all clinical development phases to influence study designs and clinical pharmacology strategies. Further responsibilities of this role are to support protocol development, study reports and regulatory documents, preclinical, clinical and CMC data interpretation, and communication of results to stakeholders.-- Cambridge Research and Development Jan 8 2021 Key Responsibilities

  • Ensure the timely delivery of translational PKPD, PBPK, population PK, exposure-response analysis, and model-based meta analysis to support key development questions addressing efficacy, safety and durability of Lentiviral Gene Therapy
  • Accountable for expert data integration, analysis, interpretation, and reporting of modeling and simulation results at the project level
  • Close collaboration with preclinical scientists, translational medicine experts, clinical, Biostats, CMC, commercial and regulatory to ensure optimal integration of modeling and simulation to address key clinical questions to support advancement of Lentiviral Gene Therapy in a timely and efficient manner
  • Execute PKPD and PBPK modeling and simulation sections in regulatory submissions
  • Perform model-based meta analysis using literature and registry data
  • Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
  • Contribute to regulatory documents and interactions (oral/written)
  • Work with other scientists to prepare and review modeling and simulation reports and other clinical pharmacology documents
  • Assist with development and validation of programming code in relevant software for PK, PKPD, PBPK, and QSP analyses
  • Co-author clinical protocols and clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing book packages, Investigator Brochures, etc.
  • Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize sampling strategies Minimum Requirements/ Qualifications
    • Ph.D. in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, Bioinformatics, Engineering, Systems Pharmacology or similar disciplines where quantitative pharmacology is emphasized
    • 3+ years of industry experience in practical applications of modeling and simulation in clinical pharmacology required
    • Significant demonstrated expertise within the field of quantitative pharmacology including PK, PKPD, and PBPK modeling
    • Demonstrated ability to identify, develop and execute strategic quantitative pharmacology activities at the project level
    • A demonstrated knowledge of regulatory, compliance, processes, and standards specific to pharmacometrics/quantitative pharmacology
    • Experience with and/or strong interest in Gene Therapy--
    • Demonstrated broad translational and clinical development expertise and experience in drug development, with emphasis on pharmacometrics/quantitative pharmacology
    • Relevant regulatory experience (written/oral)
    • Strong technical expertise with pharmacomterics and statistical software (i.e. NONMEM, R, Monolix, Matlab, PKSim, Gastroplus, SimCYP)
    • Expertise in machine learning would be a plus but not required
    • Ability to work in a demanding environment with aggressive project timelines--
    • Ability to advance multiple projects in a fast paced "biotech" environment
    • Excellent oral and written communication skills
    • Strong organizational and interpersonal skills, team player and excited to work in a matrix environment-- AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients' lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR-RD-01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO's lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

Keywords: AVROBIO, Cambridge , Quantitative Pharmacologist, Other , Cambridge, Massachusetts

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